Clostridium Difficile Infection Guideline Nov14

Clostridium difficile infection – Guideline for treatment and management. Ai-Nee Lim, Dr Michael Kelsey, Dr Julie Andrews and Patricia Folan. November 2014. Version number: 3.2.1

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Clostridium Difficile Infection Guideline for Treatment and Management

Subject: Clostridium difficile Policy Number IPC/Micro 21 Ratified By: Clinical Guidelines Committee Date Ratified: 17th March 2009 (v3), review with updates 2011,

2012, Nov 2014 Version: 3.2.1 Policy Executive Owner: Dr Richard Jennings Designation of Author: Infection Prevention & Control, Microbiology and

Pharmacy Department Name of Assurance Committee: Infection Prevention & Control Committee Date Issued: November 2014 Review Date: 3 years hence Target Audience: All clinical staff involved in prescribing, dispensing

and administering antibiotics. Doctors, nurses and pharmacists.

Key Words: Clostridium difficile, C. diff, diarrhoea, antibiotic, isolation, infection control, vancomycin, metronidazole, rifampicin, immunoglobulin, intracolonic.


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Version Control Sheet

Version Date Author Status Comment 3.0 01/06/2011 Ai-Nee Lim

(Lead Pharmacist, Antimicrobials)

Dr Michael Kelsey (Consultant Microbiologist)

Dr Julie Andrews (Consultant Microbiologist)

Patricia Folan (Infection Control Matron)

Updated Amendments:

Liquid soap must be used before entering and on leaving the room/cohort isolation bay.

Vancomycin dose increased from 125mg to 500mg.

In severe disease, metronidazole added to vancomycin therapy.

In life threatening disease, human immunoglobulin stat dose added to the treatment regimen.

3.1 01/07/2011 Updated Change in intravenous human immunoglobulin preparation used within the trust. Administration instruction amended accordingly. See section 2.3.4

3.2 01/07/2012 Updated Included guidance on interpreting laboratory C. difficile detection test results. See section 1.3

3.2.1 November2014

Infection Prevention & Control Team

Updated Updated as follows: • to highlight out of hours procedure for

samples requiring urgent testing • Communication of positive results • Insertion of Appendix 5 - C.diff care plan • Clarification of PPE


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Any patient with diarrhoea that is not attributable to any other cause AND occurring at the same time as a positive Glutamate Dehydrogenase (GDH) test and toxin assay (with or without a positive C. difficile culture) and/or endoscopic evidence of pseudomembranous colitis.

Patients may occasionally present with tender or distended abdomens with little or no diarrhoea. The diagnosis of ‘toxic megacolon’ must be considered and urgent surgical opinion must be sought, as there is a risk of large bowel perforation. C. difficile is a gram-positive, anaerobic spore-forming bacillus that is spread by the faecal-oral route, through the ingestion of spores acquired from contaminated environment or contact with healthcare staff and patients. The organism colonises the bowel in patients whose normal bowel flora has been disrupted by broad-spectrum antibacterials. Exotoxins (toxin A and toxin B) produced damages the cell lining in the intestine, resulting in diarrhoea.

Table 1: Antibacterials implicated in C. difficile infection

Some individuals may become asymptomatic carriers, while others develop symptomatic C. difficile infection. Clinical feature of C. difficile infection ranges from mild diarrhoea to very severe illness with ulceration and bleeding from the colon (colitis) and, at worst, perforation of the intestine leading to peritonitis, which can be fatal. The major host factors that predispose patients to develop C. difficile infection:

• Elderly (over 65 years) • Exposure to broad spectrum antibacterials e.g. cephalosporins, clindamycin, co-

amoxiclav, ciprofloxacin (up to 2 months after discontinuation) • Long length of stay in healthcare settings • Multiple and severe underlying disease • Immunocompromised • Gastrointestinal surgery / manipulation • Receiving proton pump inhibitors e.g. omeprazole, lansoprazole Some strains of C. difficile such as ribotype 027 may cause more severe disease and have higher mortality rates than previous circulating strains e.g. ribotypes 001 and 106.

Common Less common Rare Cephalosporins Tetracyclines Metronidazole

Clindamycin Macrolides Vancomycin Co-amoxiclav Co-trimoxazole Aminoglycosides

Amoxicillin Rifampicin Quinolones Trimethoprim

Piperacillin/Tazobactam

Criteria for use

Background


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Large outbreaks of C. difficile with significant mortality have been documented in healthcare facilities. Since January 2004, C. difficile has been part of the mandatory surveillance programme for healthcare associated infections (HCAIs). Stringent antimicrobial stewardship and aggressive infection control measures are essential in preventing secondary spread. Hand washing with soap and water is the recommended method of hand hygiene; as it is shown to be more effective than alcohol handrub at removing C. difficile spores. Clinicians (doctors and nurses) should apply the SIGHT mnemonic protocol when managing potentially infective diarrhoea:

S Suspect that a case may be infective where there is no clear alternative cause for diarrhoea

I Isolate the patient within 2 hours of the start of diarrhoea

G Gloves and aprons must be used for all contact with the patient and their environment

H Hand decontamination with soap and water or alcohol gel must be carried out before each contact with the patient or the patient’s environment. After each contact with the patient or the patient’s environment hands must be washed with soap and water

T Test the stool for toxin by sending a specimen immediately

1.1 INVESTIGATIONS

1.1.1 Send fresh stool specimen for C. difficile detection and for culture as soon as infective diarrhoea is suspected. If the diarrhoea occurs at the weekend or over bank holidays and an urgent result is required, a member of the Consultant’s team will need to contact the laboratory to ask for the specimen to be processed. If no call is received the specimen will not be processed until the next working day.

Important: In order for the specimen to be processed for C. difficile, the sample must take on the shape of the container and be at least ¼ filled (to indicate the patient has diarrhoea).

If the first test is negative but there is a strong clinical suspicion, a second stool

sample may be re-sent 24 hours later.

Do NOT send repeat stool sample within 28 days of a previous toxin POSITIVE result as it will not be tested.

Key Principle

1. Assessment


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All positive results are verbally communicated to the ward staff and highlighted in the patient’s medical notes with a ‘Clostridium difficile Alert Sticker’ by the Infection Prevention & Control Team as well as an alert on the Medway Electronic Patient Record (EPR) system.

1.1.2 Monitor frequency and severity of diarrhoea using the Stool Record Chart (see

Appendix 3).

1.1.3 Monitor urea, electrolytes and albumin

1.1.4 Monitor full blood count.

1.1.5 Consider abdominal X-ray and/or CT (computerised tomography) scan in patients with tender or distended abdomens.

1.1.6 Flexible sigmoidoscopy and biopsy can be useful where the Clostridium difficile result is negative but clinical suspicion remains high.

C. difficile infection should be managed as a diagnosis in its own right and

patients should be reviewed daily. 1.2 SEVERITY PREDICTORS

Assess severity of disease each day defining:

1.2.1 Mild Disease < 3 stools of type 5, 6 or 7 on the Bristol Stool Chart per day. NO raised WCC (white cell count).

1.2.2 Moderate Disease

3 to 5 stools of type 5, 6 or 7 on the Bristol Stool Chart per day AND a raised WCC that is < 15 x 109/L

1.2.3 Severe Disease

WCC > 15 x 109/L or temperature of > 38 °C or albumin < 25g/L or acute rising serum creatinine (> 50% increase above baseline) or evidence of severe colitis (abdominal or radiological signs)

The number of stools may be a less reliable indicator of severity

1.2.4 Life-threatening Disease Hypotension (systolic BP < 95mmHg) or partial / complete ileus or toxic megacolon or CT evidence of severe disease

1.3 INTERPRETING LABORATORY TEST RESULTS

The presence of toxin (Toxin EIA positive) is significantly associated with a poor clinical outcome and requires mandatory reporting to the Health Protection Agency. The presence of C. difficile in the absence of toxin (GDH EIA positive but Toxin EIA negative) is associated with clinical outcomes similar to that of C. difficile negative samples. However, it indicates potential C. difficile excretors with infection prevention and control implications. The following actions should be taken in relation to the C. difficile test result:


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Test Interpretation Action GDH EIA Toxin EIA

Positive Positive CDI likely to be present.

Mandatory reporting to HPA. Inform patient of test result. IPCT to send letter to GP informing them of result and requesting antibiotic/PPI history. IPCT to ensure specimen sent for ribotyping If more than 48 hrs after admission, IPCT to investigate and complete Datix. Ward area to complete HII7 form

Positive Negative C. diff could be present i.e. potential C. diff excretor.

NOT for mandatory reporting. Local reporting.Continue transmission precautions as may have transmission potential.

Negative Negative C. diff or CDI is very unlikely to be present.

NOT for mandatory or local reporting. Consider other causes of diarrhoea; if not infective consider ending isolation.

2.1 INITIAL MANAGEMENT 2.1.1 Commence ‘Diarrhoea and Clostridium difficile Transmission Precautions Core

Care Plan’ for all symptomatic patients (see Appendix 5). 2.1.2 Review ALL antibiotic use with Microbiology. Discontinue precipitating antibiotic,

if possible, or substitute with antibiotic(s) that have a lower propensity to induce C. difficile infection (see table 1, page 3).

2.1.3 Stop all drugs that might cause diarrhoea, e.g. laxatives, as well as PPIs (proton

pump inhibitors) unless required acutely. 2.1.4 Administer fluid and electrolytes (orally or intravenously) to maintain hydration. 2.1.5 Consider nutritional supplementation especially in elderly patients. 2.1.6 Avoid antimotility agents such as loperamide and opioids in acute infection as

they may delay the clearance of the toxin and exacerbate toxin-mediated colonic injury, or may precipitate ileus leading to toxic dilation of the colon.

In 15 – 23% of patients, symptoms resolve within 48 – 72 hours of stopping the offending antibiotic and without specific antimicrobial therapy.

2.2 MEDICAL TREATMENT IF SYMPTOM IS SEVERE OR PERSISTENT (also see Additional Prescribing Information and Appendix 1 & 2 below). Treat according to the severity of the infection:

2. Treatment

Abbreviations: GDH = glutamate dehydrogenase (antigen that is produced in high amounts by C. difficle, both toxin and non-toxin producing), EIA = enzyme immunoassay, CDI = C. difficile infection, HPA = Health Protection Agency, IPCT = Infection Prevention & Control Team, HII7 = High Impact Intervention No. 7 investigation form.


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2.2.1 Mild Disease

Metronidazole 400mg PO 8-hourly for 10 to 14 days

2.2.2 Moderate Disease

Metronidazole 400mg PO 8-hourly for 10 to 14 days

2.2.3 Severe Disease

Metronidazole 500mg IV 8-hourly plus Vancomycin 500mg PO 6hrly for 10 – 14 days Consider adding any of the following only if approved by Microbiology: (also consult gastroenterology and/or surgical team)

• Human immunoglobulin 400mg/kg IV as a single dose. Repeat at 21 days if necessary.

• Intracolonic vancomycin 500mg given as a retention enema 4 to 12-hourly

2.2.4 Life Threatening Disease Vancomycin 500mg PO 6-hourly for 10 to 14 days plus Metronidazole 500mg IV 8-hourly for 10 to 14 days plus Human immunoglobulin 400mg/kg IV as a single dose. Repeat at 21 days if necessary. (Consult Microbiology before prescribing. Register patient on IVIg database with Haematology team) OR

Vancomycin 500mg PO 6-hourly for 10 to 14 days plus Rifampicin 300mg PO 12-hourly for 10 to 14 days plus Human immunoglobulin 400mg/kg IV as a single dose. Repeat at 21 days if necessary. (Consult Microbiology before prescribing. Register patient on IVIg database with Haematology team) Consider adding only if approved by Microbiology: (also consult gastroenterology and/or surgical team)

• Intracolonic vancomycin 500mg given as a retention enema 4 to 12-hourly

IMPORTANT: Consult surgical team immediately if patient develops signs of peritonism or if caecal dilatation is > 10cm.

2.2.5 First recurrence Repeat the same antimicrobial used to treat the initial episode UNLESS the recurrence is more severe, in which case treat according to the severity as above.

2.2.6 Subsequent (3rd episode) Vancomycin 500mg PO 6-hourly

FOLLOWED if necessary by vancomycin taper/pulse therapy.

2.2.7 If diarrhoea persists despite 20 days’ treatment but patient is stable, number of Bristol Stool Chart type 5, 6 or 7 stools per day has decreased, WCC is normal and there are no abdominal pains or distension

Persistent diarrhoea may be due to post-infective irritable bowel syndrome.


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Consider using anti-motility agent (instead of metronidazole or vancomycin): Loperamide 2mg after each loose stool PRN up to a maximum of 16mg daily or Donor stool transplant

IMPORTANT: Observe patient closely for evidence of a therapeutic response and to ensure there is no evidence of colonic dilatation.

Diarrhoea should resolve within 1 to 2 weeks. THERAPEUTIC FAILURE should not be determined until treatment has been given for at least 1 week.

SYMPTOM FREE STATUS is achieved when the patient has no diarrhoea type 5, 6 or 7 on the Bristol Stool Chart for at least 48 hours and has had at least one formed stool, type 1, 2, 3 or 4. Patient may be discharged to complete the treatment at home.

2.3 ADDITIONAL PRESCRIBING & ADMINISTRATION INFORMATION 2.3.1 Vancomycin administration

a) Use vancomycin vials for oral (PO) and nasogastric (NG) administrations.

b) Reconstitute 500mg vial with 10ml of Water for Injection to give a concentration of 50mg/1ml. Draw up the required volume (e.g. 125mg = 2.5ml) and mix in 30ml of drinking water (orange juice or cordial may be used to improve palatability).

c) Reconstituted vials should be stored in a refrigerator and used within 24 hours.

d) Vancomycin capsules are reserved for patients’ discharges. A 14-day course of

vancomycin capsules cost £340 compared to £90 for vancomycin vials.

Important: Do NOT give vancomycin INTRAVENOUSLY as effective intraluminal concentrations cannot be achieved by that route.

2.3.3 Vancomycin taper/pulse therapy (6-week course):

125mg QDS for one week THEN 125mg TDS for one week THEN 125mg BD for one week THEN 125mg OD for one week THEN

125mg on ALTERNATE DAYS for one week THEN 125mg EVERY THIRD DAY for one week THEN STOP

2.3.2 Intracolonic vancomycin

a) Reconstitute ONE 500mg vial with 10ml of Water for Injection. Dilute the contents of into 100 – 500ml of Sodium Chloride 0.9%. Insert an 18 gauge Foley catheter with a 30ml balloon into the rectum and inflate the balloon. Instil the vancomycin solution and clamp the catheter for 60 minutes. Deflate and remove catheter when complete.

b) Intracolonic vancomycin solution can also be instilled through the colostomy,

ileostomy or rectocolonic stoma.


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2.3.4 Human Immunoglobulin 100mg/ml intravenous infusion (Privigen®)

a) Obtain approval from Microbiology before prescribing. b) Contact Haematology team to register patient on the Human Immunoglobulin

(IVIg) database. c) Ensure that all patients are well hydrated prior to initiation, and avoid

concomitant use of loop diuretic if possible. In patients with acute renal failure, use a minimum dose and slower rate of infusion.

d) For obese patients (>20% above Ideal Body Weight), the 400mg/kg dose

should calculated using the Corrected Body Weight:

Ideal body weight (IBW) / kg: IBW for males = 50 + (2.3 x every inch over 60) IBW for female = 45.5 + (2.3 x every inch over 60))

Corrected Body Weight (CBW) / kg: CBW = IBW + 0.4 (actual body weight - IBW)

e) Test dose: Initially infuse at a rate of 0.3ml/kg/hour for 30 minutes.

If well tolerated: Increase the rate of administration incrementally within 30 minutes intervals from 0.6ml/kg/hour to 1.2ml/kg/hour and so on, up to a maximum rate of 4.8ml/kg/hour for the remainder of the infusion.

f) Monitor closely for symptoms of adverse reactions throughout the infusion

period. g) Commonly reported adverse effects include hypotension, allergic and

hypersensitivity type reactions, headache, chills, back pain, chest pain, fever, hot flushes, cutaneous reactions, fatigue and nausea. Severe adverse effects (usually related to rate of infusion) include anaphylaxis, circulatory shock, acute renal failure, arterial venous thromboembolism and transfusion transmitted infection.

h) If adverse reaction occurs, either reduce the rate of infusion or stop the infusion

depending on the nature and severity of the side effect. Adrenaline should be available for treatment of any acute anaphylactoid reaction.

i) Monitor urine output and serum creatinine.

Please see Whittington Hospital NHS Trust Guidelines:

‘Intravenous Immunoglobulin Use’


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3.1 TRANSMISSION PRECAUTIONS Isolation requirement

3.1.1 Isolate symptomatic patient in a side room as soon as possible (within 2 hours) after diagnosis. Infection Control Team and/or Bed Manager should be notified.

3.1.2 Endeavour to provide an en-suite toilet facility, or at the very least allocate a designated commode for the patient.

3.1.3 Inform all staff including housekeeper / domestic staff of patient’s C. difficile status.

3.1.4 Inform patient and / or relatives of C. difficile status and provide information leaflet on C. difficile.

3.1.5 The isolation sign must be attached on the door of the side room.

3.1.6 Yellow aprons and non-sterile gloves must always be available on the outside of the room.

3.1.7 Ensure that there is a yellow bin within the room.

3.1.8 Ensure that all sinks and liquid soap dispensers are in working condition.

3.1.9 Remind all staff and visitors of the Hand-Hygiene Policy.

3.1.10 Patient may be removed from isolation when a ‘symptom free status’ is attained i.e. no diarrhoea type 5, 6 or 7 on the Bristol Stool Chart for at least 48 hours and one formed stool has been achieved.

Transferring or moving a symptomatic patient

3.1.11 Avoid transferring or moving symptomatic patient, if possible.

3.1.12 Ensure that the Infection Control Team and/or Bed Manager are aware of any transfer.

3.1.13 Notify receiving ward, department or hospital of patient’s diarrhoea/ C. difficile status in advance.

3.1.14 Obtain confirmation that infection control measures are in place before transferring patient.

3.1.15 For visits to clinics, imaging, endoscopy or theatre, patient should be seen at the end of the working session. Time spent in the department should be kept to a minimum and patient should not be left in a waiting area with other patients.

3.1.16 Staff in close contact with the patient or the contaminated environment should wear yellow aprons and non-sterile gloves, and undertake hand decontamination with soap and water after dealing with the patient.

3.1.17 Equipment and the number of staff attending the patient should be kept to a minimum.

3.1.18 After use, clean all surfaces including trolleys or chairs, which sustain patient contact, with Actichlor Plus 1,000 ppm (1 tablet in 1 litre of water). Equipment must be appropriately cleaned and disinfected according to protocol. Linen should be treated as infected and double bagged in a red bag in accordance with the Linen Policy.

3. Infection Control


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Patient discharge

3.1.19 Patient may be discharged to complete C. difficile treatment at home or nursing home if patient is medically fit and a ‘symptom free status’ is attained i.e. no diarrhoea type 5, 6 or 7 on the Bristol Stool Chart for at least 48 hours and one formed stool has been achieved.

3.1.20 Inter-hospital transfer should be accompanied with a transfer form citing patient’s diarrhoea/ C. difficile status.

Vacated bed space

3.1.21 Staff nurses must inform the housekeeper or domestic staff that a FULL TERMINAL CLEANING is required for the bed space (see section 3.3).

3.2 HAND HYGIENE Staff members

3.2.1 Use liquid soap and water or alcohol gel before entering the room

3.2.2 Wear yellow apron and non-sterile gloves before having any contact with the patient and/or their environment. If there is no contact with the patient or environment, e.g. leaving a food tray, then apron and gloves will not be required.

3.2.3 Discard apron and gloves in the yellow bin and wash hands with liquid soap and water on LEAVING the room or between DIRTY and CLEAN procedures on the same patient.

Visitors

3.2.4 Use liquid soap and water or alcohol gel before entering the room.

3.2.5 On leaving the room, wash hands with liquid soap and water.

NB: Gloves and apron NOT required UNLESS involved with patient care or visiting other hospital patients.

3.3 ENVIRONMENTAL CLEANING Daily

3.3.1 The side room should be treated as an infected area and requires daily cleaning with Actichlor Plus 1,000 ppm (1 tablet in 1 litre of water).

3.3.2 Commodes, en-suite / ward toilets and bathroom areas along with the ward sluice should be thoroughly cleaned with Actichlor Plus 10,000 ppm (10 tablets in 1 litre of water) after every use. Surfaces should be wiped or mopped twice with the solution, using a fresh cloth or mop for both occasions

Please see Whittington Hospital NHS Trust Guidelines:

‘Hand Hygiene Policy’


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3.3.3 Used linen should be treated as infected and double bagged in a red bag in accordance with the Linen Policy.

Terminal cleaning

3.3.4 All surface areas including locker, chair, table, lamp, doors, walls, floor, en-suite toilet and/or shower facility must be thoroughly cleaned with Actichlor Plus 1,000 ppm.

3.3.5 All re-usable clinical equipment must be cleaned and decontaminated with Actichlor Plus 1,000 ppm before returning to general use.

3.3.6 Mattress should be cleaned with Actichlor Plus 1,000 ppm or sent away for cleaning if heavily contaminated. Arrangement will need to be made for pressure mattress.

3.3.7 Curtains must be changed.

Definition:

A period of increased incidence (PII): Two or more cases of C.difficile infection (occurring > 48 hours post admission) in a 28-day period on a ward. An outbreak: Two or more cases cause by the same strain related in time and place over a defined period that is based on the date of onset of the first case.

Actions to be undertaken following identification of a PII or outbreak:

a) Clinical director, Head of Nursing, matron, ward manager and directorate manager must be urgently informed.

b) The DIPC and/or the duty microbiologist with the clinical director and

consultants will determine the need for an incident meeting, depending on the size and rate of growth of the PII.

c) All isolates from patients in the ward will be sent for PCR (polymerase chain

reaction) ribotyping.

d) In an outbreak, the ward manager / charge nurse will complete a Clinical Incident Form and the senior manager will need to fill a Trust SUI (serious untoward incidents) form.

e) Restriction of admissions to and transfer from affected area(s) will be

implemented.

f) The ward will be subjected to a root cause analysis.

g) An audit of outbreak management will be undertaken by the Infection control team utilising the DH Saving Lives Clostridium difficile High Impact Intervention (HII) tool.

4. Outbreaks Policy


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During working hours (Monday to Friday, 09:00 – 17:00) Infection Control team ext. 3261 or bleep 2669 Bed Manager air call via Whittington switchboard Housekeeping / Domestics ext. 5585 / 5558 / 5508 ST doctor in Microbiology bleep 3069 or ext. 5085 Consultant Microbiologist ext. 5082 / 3894 Lead Pharmacist, Antimicrobials bleep 3138 or ext. 3732

Out of hours Bed manager air call via Whittington switchboard On-call ST doctor in Microbiology air call via Whittington switchboard On-call pharmacist air call via Whittington switchboard

1. APISARNTHANARAK, A. and MUNDY, L. M. (2005) Intracolonic vancomycin for adjunctive treatment of severe Clostridium difficile colitis: Indications and precautions. J Infect Dis Antimicrob Agents; 22: 21 – 26.

2. ASLAM, S., HAMILL, R. J. and MUSHER, D. M. (2005) Treatment of Clostridium

difficile-associated disease. Old therapies and new strategies. Lancet Infect Dis; 5: 546 – 557

3. BIGNARDI, G. E. (1998) Risk factors for Clostridium difficile infection. J Hosp Infect,

40: 1 – 15

4. HEALTH PROTECTION AGENCY and DEPARTMENT OF HEALTH (2008) Clostridium difficile infection: How to deal with the problem. Available online at: www.hpa.org.uk (Accessed on 24th February 2009)

5. MONAGHAN, T., BOSWELL, T., MAHIDA, Y. R. (2008) Recent advances in

Clostridium difficile-associated disease. Gut; 57: 850 – 860

6. Summary of Product Characteristics (2007) Octagam. Octapharma Ltd. European SPC available on: www.octapharma.com (Accessed on 18/11/08)

7. MCFARLAND, L. V., SURAWICZ, C. M., GREENBERG, R. N. et al (1994) A

randomised placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. JAMA, 271 (24) 1913 - 1918

8. TUNG, J. M., DOLOVICH, L. R. and LEE, C. H. (2009) Prevention of Clostridium

difficile infection with Saccharomyces boulardii: a systematic review. Can J Gastroenterol, vol 23 (12) pp 817 – 821

9. Department of Health (2012) Updated guidance on the diagnosis and reporting of

Clostridium Difficile. Gateway reference: 17215. Available at: http://www.dh.gov.uk/publications

Contacts

References


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Key aspects of the guidelines will be monitored as part of the annual antimicrobial audit

programme.

Compliance with this guideline (how and when the guideline will be monitored e.g. audit and which committee the results will be reported to) Please use the tool provided at the end of this template


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ALGORITHM FOR THE TREATMENT OF 1ST OR 2ND EPISODE OF CLOSTRIDIUM DIFFICILE INFECTION

c) –

Diarrhoea not attributable to any other cause AND clinically consistent with C. diff infection (CDI) and/or endoscopic evidence of pseudomembranous colitis

Appendix 1: Treatment Algorithm – 1st or 2nd Episode

Initial management

Discontinue precipitating antibiotic or substitute with antibiotic(s) with lower risk. Avoid drugs that may cause diarrhoea and PPIs, unless required acutely. Avoid antimotility agents e.g. loperamide and opioids Consider fluid resuscitation, electrolyte replacement and nutritional review.

Daily Assessment

Moderate Disease

3 – 5 episodes of diarrhoea per day AND

Raised WCC but < 15 x 109 / L

Mild / Moderate Disease

Metronidazole 400mg PO 8 hrly for 10–14 days

Severe Disease

WCC > 15 x 109 / L or

Temperature > 38.5°C or

Albumin < 25 g/L or

Acute rising creatinine (>50% above baseline) or

Evidence of severe colitis

Life Threatening

Hypotension (systolic BP < 95mgHg) or

Partial / complete ileus or

Toxic megacolon or

CT evidence of severe disease

Dis

ease

sev

erity

Mild Disease

< 3 episodes of diarrhoea per day

No raised WCC

Refractory or Worsening Cases

Switch to: Vancomycin 500mg PO 6 hrly + Metronidazole 500mg IV 8 hrly

for 10–14 days

DO NOT GIVE VANCOMYCIN INTRAVENOUSLY

IF SYMPTOMS NOT IMPROVING OR WORSENING

Diarrhoea should resolve within 1– 2 weeks. Therapeutic failure is not determined until treatment has been given for at least 1 week.

Consult Microbiology, Surgical & Gastroenterology team

Consider adding the following only if approved by Microbiology (also consult surgical and/or gastroenterology team)

Human immunoglobulin (Privigen®) 400mg/kg IV as a single dose. Repeat at 21 days if necessary. Intracolonic vancomycin 500mg given as a retention enema over 60 minutes every 4 – 12 hours.

Severe Disease

Vancomycin 500mg PO 6 hrly + Metronidazole 500mg IV 8 hrly

for 10–14 days


Life Threatening

DISCUSS WITH MICROBIOLOGY (also consult surgical and/or gastroenterology team)

Vancomycin 500mg PO 6 hrly + Metronidazole 500mg IV 8 hrly

for 10–14 days

OR

Vancomycin 500mg PO 6 hrly + Rifampicin 300mg PO 12 hrly

for 10–14 days

plus Human Immunoglobulin 400mg/kg IV stat. Repeat at 21 days if necessary.


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ALGORITHM FOR THE TREATMENT OF RECURRENT (3RD OR SUBSEQUENT) EPISODE

OF CLOSTRIDIUM DIFFICILE INFECTION

Appendix 2: Treatment Algorithm – 3rd or Subsequent Episode

Initial management

Discontinue precipitating antibiotic or substitute with antibiotic(s) with lower risk. Avoid drugs that may cause diarrhoea and PPIs, unless required acutely. Avoid antimotility agents e.g. loperamide and opioids Consider fluid resuscitation, electrolyte replacement and nutritional review.

Daily Assessment

Mild / Moderate Disease

Vancomycin 500mg PO 6 hourly for 14 days


Severe or Life Threatening Disease

See Appendix 1: Treatment Algorithm for 1st or 2nd Episode of Clostridium Difficile

Diarrhoea should resolve within 1– 2 weeks. Recurrence occurs in around 20% after the 1st episode and 40 – 50% after the 2nd or 3rd episode.

Multiple Recurrences (especially if evidence of malnutrition, wasting, etc.) Consider the following

Consult Microbiology/Surgical/Gastroenterology team regarding:

Review ALL antimicrobial and other drug therapy e.g. consider stopping PPIs and/or other gastrointestinal active drugs.

Trial of anti-motility agents alone if NO abdominal symptoms or signs of severe Clostridium difficile infection. Obtain approval from Microbiology (also consult Surgical / Gastroenterology team) for:

Vancomycin taper / pulse therapy. Human immunoglobulin (Privigen®) 400mg/kg IV as a single dose, especially if worsening albumin. Donor stool transplant.

Diarrhoea not attributable to any other cause AND clinically consistent with C. diff infection (CDI) and/or endoscopic evidence of pseudomembranous colitis


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STOOL CHART

Date Time Volume * Bristol

stool type 1 – 7

Colour Blood MucusContains food particles

Occult blood Signature & print name Job title

Appendix 3: Stool Record Chart

Patient Name: …………….……..…..……… Hospital Number: ..…………………………. Ward:……………………. DoB:…….………

* Refer to Bristol Stool Scale chart in the dirty utility area for definitions of types 1 to 7

Scores 1-3: indicates constipation – encourage fluids and high fibre diet. Refer to doctors Score 4: indicates a normal stool Scores 5-7: indicates diarrhoea – commence source isolation procedures, send a specimen for MC&S and

inform nurse in charge and doctor


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Appendix 4: Bristol Stool Scale Chart

The Bristol Stool Chart or Bristol Stool Scale is a medical aid designed to classify faeces into seven groups. It was developed by K. W. Heaton and S. J. Lewis at the University of Bristol and was first published in the Scandinavian Journal of Gastroenterology in 1997. The form of the stool depends on the time it spends in the colon.


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NAME: HOSP. No: WARD PROBLEM NUMBER: (one per page) Date & Time

PATIENT PROBLEM/NEED

RN SIGNATURE

Review Date

…………………………………. has diarrhoea Diarrhoea symptoms commenced on …….…………(date) (bristol score 5 – 7) Date & Time

GOAL/AIM

RN SIGNATURE

ReviewDate

Minimise the risk of cross infection and contamination from diarrhoea Date & Time

PLANNED NURSING INTERVENTIONS

RN SIGNATURE

Review Date

a. Introduce yourself - initiate patient /nurse relationship 1. Specimens a. Date stool specimen sent…………………………. 2. Documentation and Communication c. Inform doctor of diarrhoea d. Inform patient / relatives of reason for isolation e. Commence stool chart f. Commence fluid balance chart g. Record result in clinical notes h. Record result in nursing handover sheet i. Inform doctor of result j. Inform patient/relatives of result & give reassurance If confirmed GHD or C. Diff give appropriate leaflet 3. Isolation (transmission precautions) k. Nurse patient in side room as soon as symptoms develop (Do not wait for diagnosis) reassure your patient l. If en-suite side room not available designate a commode for patient (Keep in room) m. Isolation sign on door n. Yellow aprons & gloves outside door/on trolley o. Orange bags in room or cohort bay p. Sink- soap and paper towels available in room q. Alcohol gel available outside room 4. Hygiene (Remind all staff and visitors) Use hand gel or hand wash before entering room or bay s. Wear apron and gloves before any contact with patient or environment t. Discard apron & gloves in orange bin and wash hands before leaving room or between procedures on same patient u. Use alcohol hand rub after leaving the room

Location record to be completed for ALL patients Date Ward *Location in ward Bed / SR No Reason patient was moved Original location when diarrhoea started:

*Location key: a = side room b = cohort bay c = open bay GDH / C diff information overleaf

confirm I have discussed this care plan with………………………….signed……………………..designation……

Appendix 5: DIARROHEA / C DIFFICILE PRECAUTIONS - NURSING CORE CARE PLAN


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Information

Glutamate Dehydrogenase (GHD) Positive result GHD positive result means that there is Clostridium Difficile (C Diff) present in the bowel, that is colonisation. Being GHD positive does not mean that diarrhoea is caused by C. Diff (unless the stool also contains C. Diff toxins) Patient will need to be isolated and precautions taken Clostridium Difficile (C Diff) toxin positive result If the specimen is GHD positive it will automatically be further tested for C Diff toxins. A specimen that is C. Diff positive means that the diarrhoea is caused by C. Diff infection. This means the C. Diff colonisation has multiplied to cause infection. Patient will need to be isolated and precautions taken.

GDH Toxin Result Nursing location Negative N/A Diarrhoea is not caused by C difficile Standard precautions Positive Negative C difficile present but is not causing infection Isolation/cohort Positive Positive C difficile is causing the infective diarrhoea Isolation/cohort

Repeat stool specimens Repeated diarrhoea stool specimens sent within 28 days of a positive C. Diff stool result will not be processed again for clostridium difficile toxins. De-Isolation Your patient can come out of the side room if:

1. They have not had diarrhoea for 48 hours 2. PLUS – very importantly – they have passed a normal formed stool (Bristol score 1-4)

Diarrhoea recommences in positive patient It is possible for the patient to suffer from diarrhoea again. Should this occur then they must be returned to isolation again. (Commence new care plan.) Transferring a GHD positive and / or C diff positive patient to another care facility

• Notify the receiving area in advance • Notify the ambulance crew in advance


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To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval

Yes/No Comments

1. Does the procedural document affect one group less or more favourably than another on the basis of:

• Race No

• Ethnic origins (including gypsies and travellers)

No

• Nationality No

• Gender No

• Culture No

• Religion or belief No

• Sexual orientation including lesbian, gay and bisexual people

No

• Age No

• Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2. Is there any evidence that some groups are affected differently?

No

3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable?

No

4. Is the impact of the procedural document likely to be negative?

No

5. If so can the impact be avoided? N/A

6. What alternatives are there to achieving the procedural document without the impact?

N/A

7. Can we reduce the impact by taking different action?

N/A

If you have identified a potential discriminatory impact of this procedural document, please refer it to the Director of Human Resources, together with any suggestions as to the action required to avoid/reduce this impact. For advice in respect of answering the above questions, please contact the Director of Human Resources.


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Checklist for the Review and Approval of Procedural Document To be completed and attached to any procedural document when submitted to the relevant committee for consideration and approval.

Title of document being reviewed: Yes/No Comments

1. Title

Is the title clear and unambiguous? Yes

Is it clear whether the document is a guideline, policy, protocol or standard?

Yes

2. Rationale

Are reasons for development of the document stated?

Yes

3. Development Process

Is it clear that the relevant people/groups have been involved in the development of the document?

Yes

Are people involved in the development? Yes

Is there evidence of consultation with stakeholders and users?

Yes

4. Content

Is the objective of the document clear? Yes

Is the target population clear and unambiguous?

Yes

Are the intended outcomes described? Yes

5. Evidence Base

Are key references cited in full? N/A

Are supporting documents referenced? N/A

6. Approval

Does the document identify which committee/ group will approve it?

Yes

7. Dissemination and Implementation

Is there an outline/plan to identify how this will be done?

Yes

8. Document Control

Does the document identify where it will be held?

Yes

9. Process to Monitor Compliance and Effectiveness

Are there measurable standards or KPIs to support the monitoring of compliance with

Yes


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Title of document being reviewed: Yes/No Comments

and effectiveness of the document?

Is there a plan to review or audit compliance with the document?

Yes

10. Review Date

Is the review date identified? Yes

Is the frequency of review identified? If so is it acceptable?

Yes

11. Overall Responsibility for the Document

Is it clear who will be responsible for co-ordinating the dissemination, implementation and review of the document?

Yes

Executive Sponsor Approval If you approve the document, please sign and date it and forward to the author. Procedural documents will not be forwarded for ratification without Executive Sponsor Approval Name Date Signature

Relevant Committee Approval The Director of Nursing and Patient Experience’s signature below confirms that this procedural document was ratified by the appropriate Governance Committee. Name Date Signature

Responsible Committee Approval – only applies to reviewed procedural documents with minor changes The Committee Chair’s signature below confirms that this procedural document was ratified by the responsible Committee Name Date Name of Committee

Name & role of Committee Chair

Signature

Clostridium difficile infection – Guideline for treatment and management. Ai-Nee Lim, Dr Michael Kelsey, Dr Julie Andrews and Patricia Folan. November 2014. Version number: 3.2.1 Page 24

Tool to Develop Monitoring Arrangements for Policies and Guidelines

What key element(s) need(s) monitoring as per local approved policy or guidance?

Who will lead on this aspect of monitoring?

Name the lead and what is the role of the multidisciplinary team or others if any.

What tool will be used to monitor/check/observe/Assess/inspect/ authenticate that everything is working according to this key element from the approved policy?

How often is the need to monitor each element?

How often is the need complete a report ?

How often is the need to share the report?

What committee will the completed report go to?

Element to be monitored Lead Tool Frequency Reporting arrangements

• Compliance with infection control measures

• Compliance with antibacterial treatment guideline

• Infection Control Team with support from the Visible Leadership Team (VLT).

• DIPC & Lead Antimicrobials Pharmacist with support from Microbiology and Pharmacy.

• In house audit tools.

• Infection control dashboard.

• Targeted ward antibacterial prescribing score card.

Refer to infection control & antibacterial audit programme

• Infection Prevention & Control Committee (IPCC)

• Antimicrobial Steering Group (ASG)

Documents

Clostridium Difficile Infection Guideline Nov14